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FDA 510(k)

Stonetome Stone Removal Device

K-Number: K191789 · 2019-07-25

ApplicantBoston Scientific Corporation
Decision Date2019-07-25
Product CodeLQR
Advisory CommitteeGU
DecisionUnknown

Device Summary

Stonetome Stone Removal Device is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2019-07-25 under approval number K191789. The device is classified under product code LQR. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Stonetome Stone Removal Device?

Stonetome Stone Removal Device is a medical device that received FDA 510(k) clearance on 2019-07-25. It is manufactured by Boston Scientific Corporation. The 510(k) number is K191789.

When was Stonetome Stone Removal Device approved by the FDA?

Stonetome Stone Removal Device received FDA 510(k) clearance on 2019-07-25, under approval number K191789.

What company makes Stonetome Stone Removal Device?

Stonetome Stone Removal Device is manufactured by Boston Scientific Corporation.

What is the FDA product code for Stonetome Stone Removal Device?

The FDA product code for Stonetome Stone Removal Device is LQR.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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